TPLC - Total Product Life Cycle

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Device	separator, automated, blood cell and plasma, therapeutic
Product Code	LKN
Device Class	Unclassified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	396	440
Insufficient Information	261	261
No Apparent Adverse Event	48	48
Use of Device Problem	34	34
Patient-Device Incompatibility	27	27
Fluid/Blood Leak	16	16
Improper or Incorrect Procedure or Method	16	16
Gas/Air Leak	12	12
Device Displays Incorrect Message	10	10
Obstruction of Flow	8	8
Insufficient Flow or Under Infusion	8	8
Infusion or Flow Problem	7	7
Appropriate Term/Code Not Available	6	6
Output Problem	6	6
Therapeutic or Diagnostic Output Failure	6	6
Leak/Splash	6	6
Break	5	5
Defective Device	5	5
Improper Flow or Infusion	5	5
Device Alarm System	5	5
Excess Flow or Over-Infusion	5	5
Device Handling Problem	5	5
Misassembled	5	5
Inadequate User Interface	5	5
Defective Component	4	4
Material Discolored	4	4
Mechanical Problem	3	3
Device Slipped	3	3
Coagulation in Device or Device Ingredient	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Microbial Contamination of Device	2	2
Contamination /Decontamination Problem	2	2
Air/Gas in Device	2	2
Pumping Problem	2	2
Display or Visual Feedback Problem	2	2
Human-Device Interface Problem	2	2
Component Misassembled	2	2
Contamination of Device Ingredient or Reagent	2	2
Inaccurate Flow Rate	2	2
Backflow	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Expiration Date Error	2	2
Off-Label Use	2	2
Priming Problem	1	1
Nonstandard Device	1	1
Installation-Related Problem	1	1
No Flow	1	1
Free or Unrestricted Flow	1	1
Material Deformation	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	118	118
Low Blood Pressure/ Hypotension	58	80
No Known Impact Or Consequence To Patient	57	57
Reaction	44	44
Insufficient Information	41	41
Hemolysis	40	40
Death	34	34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	32	54
Hypersensitivity/Allergic reaction	31	53
Itching Sensation	20	20
Rash	19	19
Hypervolemia	16	16
Tachycardia	15	15
Vomiting	14	23
Local Reaction	14	14
Dyspnea	13	13
Fever	13	13
Nausea	13	13
Anemia	12	12
Air Embolism	11	11
Chest Pain	11	11
Paresthesia	10	19
Electrolyte Imbalance	9	31
Sepsis	9	22
Hemorrhage/Bleeding	9	9
No Consequences Or Impact To Patient	9	9
Syncope/Fainting	9	9
Urticaria	9	9
Thrombocytopenia	8	8
Blood Loss	8	8
Cardiac Arrest	8	8
Bacterial Infection	7	7
Dizziness	7	7
Hematoma	7	7
High Blood Pressure/ Hypertension	7	7
Unspecified Infection	6	28
Swelling/ Edema	5	5
Heart Failure/Congestive Heart Failure	5	5
Pain	5	5
Liver Failure	5	5
Pulmonary Embolism	5	5
No Patient Involvement	5	5
Numbness	5	5
No Information	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Hypovolemia	4	4
Diarrhea	4	13
Erythema	4	4
Hypoxia	3	3
Cough	3	3